A Study of Overall Survival in Participants With Unresectable Hepatocellular Carcinoma

Sponsor

Eisai Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT04008082

Collaborator

(none)

412

Enrollment

Locations

32.5

Actual Duration (Months)

206

Patients Per Site

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of this study to continue follow-up of participants enrolled in the study E7080-M081-504 (NCT03663114) of lenvima capsules and to evaluate the overall survival of participants with hepatocellular carcinoma.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Hepatocellular Carcinoma Neoplasms, Glandular and Epithelial Neoplasms	Drug: Lenvatinib

Study Design

Study Type:

Observational

Actual Enrollment :

412 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Specific Use Results Survey of LENVIMA 4 mg Capsules -Observational Study of Overall Survival in Patients With Unresectable Hepatocellular Carcinoma (Study LEN03T)

Actual Study Start Date :

May 14, 2019

Actual Primary Completion Date :

Jan 28, 2022

Actual Study Completion Date :

Jan 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Lenvatinib Lenvatinib capsules 12 milligram (mg) for participants with body weight greater than or equal to (>=) 60 kilograms (kg) or 8 mg for participants with body weight less than (<) 60 kg, orally, once daily as per routine clinical practice.	Drug: Lenvatinib Lenvatinib capsule. Other Names: Lenvima E7080

Arm

Intervention/Treatment

Lenvatinib

Lenvatinib capsules 12 milligram (mg) for participants with body weight greater than or equal to (>=) 60 kilograms (kg) or 8 mg for participants with body weight less than (<) 60 kg, orally, once daily as per routine clinical practice.

Drug: Lenvatinib

Lenvatinib capsule.

Other Names:

Lenvima

E7080

Outcome Measures

Primary Outcome Measures

Overall Survival (OS) [From date of study drug administration until date of death from any cause (approximately 2.8 years)]
OS is calculated as the period from the day of starting administration to the day of death from any cause.
Presence or absence of factors with a possible influence on OS [From date of study drug administration until date of death from any cause (approximately 2.8 years)]
Factor analysis is performed according to the category of participant background (aetiology of chronic liver disease, baseline alpha-fetoprotein concentration etc), lenvima administration status and treatment situation before and after administration of lenvima, and factors affecting OS are examined. Appropriate statistical methods (Cox regression analysis, etc.) will be used to examine the relationship of OS with various factors in order to identify the factors affecting survival.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All participants enrolled in the study E7080-M081-504 with informed consent to participate in this study.

Exclusion Criteria:

Participants who do not have unresectable hepatocellular carcinoma
Participants who have not given informed consent or have withdrawn consent to participation
Participants with a history of hypersensitivity to any ingredient of lenvima
Pregnant or possibly pregnant women
Participants previously treated with lenvima (excluding those previously enrolled in the Study E7080-M081-504 [NCT03663114] at another clinical site).